CA2414349A1 - Cross-linked high amylose starch for use in controlled-release pharmaceutical formulations and processes for its manufacture - Google Patents

Cross-linked high amylose starch for use in controlled-release pharmaceutical formulations and processes for its manufacture Download PDF

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Publication number
CA2414349A1
CA2414349A1 CA002414349A CA2414349A CA2414349A1 CA 2414349 A1 CA2414349 A1 CA 2414349A1 CA 002414349 A CA002414349 A CA 002414349A CA 2414349 A CA2414349 A CA 2414349A CA 2414349 A1 CA2414349 A1 CA 2414349A1
Authority
CA
Canada
Prior art keywords
cross
amylose starch
high amylose
linked high
controlled
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002414349A
Other languages
French (fr)
Other versions
CA2414349C (en
Inventor
Vincent Lenaerts
Roland Herwig Friedrich Beck
Elsie Van Bogaert
Francois Chouinard
Reiner Hopcke
Cyril Desevaux
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Paladin Labs Barbados Inc
Paladin Labs Inc
Paladin Labs Europe Ltd
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Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=24427807&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CA2414349(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Individual filed Critical Individual
Publication of CA2414349A1 publication Critical patent/CA2414349A1/en
Application granted granted Critical
Publication of CA2414349C publication Critical patent/CA2414349C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/04—Centrally acting analgesics, e.g. opioids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • C—CHEMISTRY; METALLURGY
    • C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08B—POLYSACCHARIDES; DERIVATIVES THEREOF
    • C08B33/00—Preparation of derivatives of amylose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0024—Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue

Abstract

The present invention relates to a novel form of cross-linked high amylose starch and process for its manufacture. Such cross-linked high amylose starch is useful as an excipient in a controlled-release pharmaceutical formulation when compressed with a pharmaceutical agent(s) in a tablet. Such cross-linked high amylose starch is prepared by (a) cross-linking and chemical modification of high amylose starch, (b) gelatinization, and (c) drying to obtain a powder of said controlled release excipient. In a preferred embodiment, such cross-linked high amylose starch is prepared in following steps: (1) granular cross-linking and additionally chemical modification (e.g., hydroxypropylation) of high- amylose starch; (2) thermal gelatinization of the starch from step (1);
and (3) drying the starch from step (2) to yield a powder capable of being used as a controlled release excipient.
CA002414349A 2000-06-29 2001-06-26 Cross-linked high amylose starch for use in controlled-release pharmaceutical formulations and processes for its manufacture Expired - Fee Related CA2414349C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US09/606,399 2000-06-29
US09/606,399 US6607748B1 (en) 2000-06-29 2000-06-29 Cross-linked high amylose starch for use in controlled-release pharmaceutical formulations and processes for its manufacture
PCT/US2001/020319 WO2002002084A1 (en) 2000-06-29 2001-06-26 Cross-linked high amylose starch for use in controlled-release pharmaceutical formulations and processes for its manufacture

Publications (2)

Publication Number Publication Date
CA2414349A1 true CA2414349A1 (en) 2002-01-10
CA2414349C CA2414349C (en) 2008-09-16

Family

ID=24427807

Family Applications (1)

Application Number Title Priority Date Filing Date
CA002414349A Expired - Fee Related CA2414349C (en) 2000-06-29 2001-06-26 Cross-linked high amylose starch for use in controlled-release pharmaceutical formulations and processes for its manufacture

Country Status (27)

Country Link
US (2) US6607748B1 (en)
EP (1) EP1305009B1 (en)
JP (1) JP5025066B2 (en)
KR (1) KR100840393B1 (en)
CN (1) CN100352509C (en)
AR (1) AR029549A1 (en)
AT (1) ATE328585T1 (en)
AU (2) AU2001271481B2 (en)
BR (1) BRPI0112140B8 (en)
CA (1) CA2414349C (en)
CZ (1) CZ300152B6 (en)
DE (1) DE60120413T2 (en)
DK (1) DK1305009T3 (en)
ES (1) ES2272499T3 (en)
HK (1) HK1059574A1 (en)
HU (1) HUP0301302A2 (en)
IL (2) IL153654A0 (en)
MX (1) MXPA03000035A (en)
MY (1) MY128308A (en)
NO (1) NO20026254L (en)
NZ (1) NZ523644A (en)
PL (1) PL202177B1 (en)
PT (1) PT1305009E (en)
RU (1) RU2274443C2 (en)
SI (1) SI1305009T1 (en)
TW (1) TWI289460B (en)
WO (1) WO2002002084A1 (en)

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US9579285B2 (en) 2010-02-03 2017-02-28 Gruenenthal Gmbh Preparation of a powdery pharmaceutical composition by means of an extruder
US9629807B2 (en) 2003-08-06 2017-04-25 Grünenthal GmbH Abuse-proofed dosage form
US9636303B2 (en) 2010-09-02 2017-05-02 Gruenenthal Gmbh Tamper resistant dosage form comprising an anionic polymer
US9655853B2 (en) 2012-02-28 2017-05-23 Grünenthal GmbH Tamper-resistant dosage form comprising pharmacologically active compound and anionic polymer
US9675610B2 (en) 2002-06-17 2017-06-13 Grünenthal GmbH Abuse-proofed dosage form
US9737490B2 (en) 2013-05-29 2017-08-22 Grünenthal GmbH Tamper resistant dosage form with bimodal release profile
US9750701B2 (en) 2008-01-25 2017-09-05 Grünenthal GmbH Pharmaceutical dosage form
US9855263B2 (en) 2015-04-24 2018-01-02 Grünenthal GmbH Tamper-resistant dosage form with immediate release and resistance against solvent extraction
US9872835B2 (en) 2014-05-26 2018-01-23 Grünenthal GmbH Multiparticles safeguarded against ethanolic dose-dumping
US9913814B2 (en) 2014-05-12 2018-03-13 Grünenthal GmbH Tamper resistant immediate release capsule formulation comprising tapentadol
US9925146B2 (en) 2009-07-22 2018-03-27 Grünenthal GmbH Oxidation-stabilized tamper-resistant dosage form
US10058548B2 (en) 2003-08-06 2018-08-28 Grünenthal GmbH Abuse-proofed dosage form
US10064945B2 (en) 2012-05-11 2018-09-04 Gruenenthal Gmbh Thermoformed, tamper-resistant pharmaceutical dosage form containing zinc
US10080721B2 (en) 2009-07-22 2018-09-25 Gruenenthal Gmbh Hot-melt extruded pharmaceutical dosage form
US10130591B2 (en) 2003-08-06 2018-11-20 Grünenthal GmbH Abuse-proofed dosage form
US10154966B2 (en) 2013-05-29 2018-12-18 Grünenthal GmbH Tamper-resistant dosage form containing one or more particles
US10201502B2 (en) 2011-07-29 2019-02-12 Gruenenthal Gmbh Tamper-resistant tablet providing immediate drug release
US10300141B2 (en) 2010-09-02 2019-05-28 Grünenthal GmbH Tamper resistant dosage form comprising inorganic salt
US10335373B2 (en) 2012-04-18 2019-07-02 Grunenthal Gmbh Tamper resistant and dose-dumping resistant pharmaceutical dosage form
US10449547B2 (en) 2013-11-26 2019-10-22 Grünenthal GmbH Preparation of a powdery pharmaceutical composition by means of cryo-milling
US10624862B2 (en) 2013-07-12 2020-04-21 Grünenthal GmbH Tamper-resistant dosage form containing ethylene-vinyl acetate polymer
US10695297B2 (en) 2011-07-29 2020-06-30 Grünenthal GmbH Tamper-resistant tablet providing immediate drug release
US10729658B2 (en) 2005-02-04 2020-08-04 Grünenthal GmbH Process for the production of an abuse-proofed dosage form
US10842750B2 (en) 2015-09-10 2020-11-24 Grünenthal GmbH Protecting oral overdose with abuse deterrent immediate release formulations
US11224576B2 (en) 2003-12-24 2022-01-18 Grünenthal GmbH Process for the production of an abuse-proofed dosage form
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